Technical Field
The present disclosure relates to surgical fastener inserter instruments, and more particularly to surgical fastener inserter instruments for joining tubular sections of tissue such as intestinal anastomoses.
Background of Related Art
The present disclosure relates to anastomotic devices for the formation of anastomoses and, in particular, to intestinal anastomoses. In surgery, operationally produced connections between blood vessels, nerves and hollow organs, like, for example, sections of the large intestines, are designated as an anastomoses. Fundamentally, the anastomosis is understood as a connection between two anatomical structures. For producing anastomoses, anastomotic devices of different design can be used, in particular the so called fastener inserters or clamp inserters. While carrying out surgical clamping operation with such a clamp inserter, two tissue parts and/or areas are interconnected by a set of clips, which form a body lumen in each case, such as, for example, two separate large intestine parts.
DE application no. 10 2007 057 207 A1 discloses a surgical clamp inserter for forming anastomoses, which ejects the clamps from a head section and brings them into an anvil section. The head section has a hollow-cylindrical head section facing the anvil section, and an retractable and extendable knife is arranged in the head section. The head section takes up a clamp device. Within an area surrounded by the head section, a retractable and extendable retaining pin or trocar tip is arranged, with which the anvil section is connected. The anvil section is provided with an arrangement of clamp shaping recesses, wherein the clamps are driven into the tissue and the clamps at the anvil section are formed or remodeled by manipulating the clamp device. For the formation of an intestinal anastomosis, a section of the intestine having a pathological tissue is removed in the first step. The intestine is divided into a first section with a proximal end and a second section area with a distal end, whereby the sections must be joined by a link again, in order to reproduce the continence. This connection with clamp inserter is known from DE application no. 10 2007 057 207 A1. The anvil section has a thrust bearing part, which is removed from the head section and inserted with a so-called purse-string suture into the proximal end of the first section of the intestine. The open end of the distal end of the second section is sutured with a cross suture. Subsequently, the head section of the anastomotic device (without the anvil section) is introduced through the anus and then up to the sealed end of the second section of the intestine. Afterwards the cross suture of the second section is punctured by the retaining pin of the head section, and the retaining pin forms a positive connection with the thrust bearing part of the anvil section. The retaining pin is now telescoped into the head section with the coupled thrust bearing part, which is located in the first section of the intestine, so that the sections of tissue are clamped together. The thrust bearing part is moved against the head section, so that a clamping and the subsequent separation of the surplus tissue can be accomplished. After re-establishing the continence, the anastomotic device is retracted completely from the body lumen and removed from the anus.
Well-known anastomotic devices have the disadvantage that the surrounding body tissue often gets damaged during insertion into the body lumen and thus leads to pain after the operation. This occurs in particular with such anastomotic devices, which have a sharp edged head-section and enlarged in the distal direction. The forward movement of the head section within the body lumen, in particular with heavily lined intestinal mucosa, is then clearly affected and the operational risk increased.
In order to effectively avoid injury to the body, in particular to the anal canal, while inserting the head section of clamp inserter, as known from DE application no. 10 2007 057 207 A1, into the body of the patient, in case of the known clamp inserter a provision is made such that in the anvil section removed by the trocar tip the front end of the head section can be covered by a cap. The cap is attached to the trocar tip. The trocar tip is extended such that with attached cap the cap covers the front end of the head section, thus fitting the same. Therefore, the cap covers at least those front areas of the head section, which are relatively sharp edged and can lead to injuries while inserting the head section through the anal canal. While inserting the equipment, the cap executes thus the function of a protective cap. Using the cap, a thread arranged outside of the device is connected, wherein for removing the cap the trocar tip is inserted, so that the trocar tip is disengaged with the cap. The cap can be taken off the head section without laterally touching at the head section by means of the thread present on the cap and remains laterally apart from the head section. After the clamping process and/or connecting the two intestine ends, the clamp inserter is pulled through the anal canal out of the body of the patient. The cap is pulled out by means of the thread through the anal canal. In the case of known clamp inserter, it is disadvantageous that the cap is taken off via a thread from the head section and afterwards remains by the side of the head section. When taking out the thread and by arranging the cap beside the head section it can cause injuries to the surrounding tissue in case of movement of the head section. In all other respects, it can be seen that taking off the cap with the thread is not easily possible, if the head section on the side of the thread lies close against the tissue. Even pulling the cap out of a body lumen with the help of the thread is difficult and can lead to further injuries of the body tissue.
There is a need to make available an anastomotic device of the kind described earlier, which would allow easy insertion into a body lumen and with a less danger of injuries to the surrounding body tissue. Further, the said anastomotic device should allow a leak test before by surgery of a sealed, in particular, the sutured opening of the body lumen, such as, for example, the leak test of a cross suture in a distal portion of the large intestine.